Comparative efficacy and safety of silodosin (Silorap®) versus tamsulosin (Tamsolin®) for medical expulsive therapy of distal ureteral stones
Abstract Purpose The study objective was to compare the efficacy and safety of Silodosin (Silorap ® ) versus Tamsulosin (Tamsolin ® ) in facilitating the passage of acutely obstructing distal ureteral stones. Methods This multicenter, randomized, comparative study enrolled 336 adult patients with a single distal ureteric calculus (5–10 mm) across sixteen tertiary care centers in Pakistan. Participants were randomized to receive Silodosin (Silorap ® ) or Tamsulosin (Tamsolin ® ) and followed for 30 days. Primary outcome was stone expulsion rate at four weeks; secondary outcomes included time to expulsion, analgesic use, emergency visits, and safety outcomes. Results Baseline characteristics were comparable between groups. The stone expulsion rate was significantly higher with Silodosin (112/166; 67.47%) than with Tamsulosin (92/170; 54.12%; p = 0.012). Mean expulsion time was 13.68 ± 8.97 days for Silodosin and 14.33 ± 9.65 days for Tamsulosin (median 12 days; p = 0.701). Kaplan–Meier analysis showed similar time to passage (log-rank p = 0.728). Pain scores declined significantly in both groups. Both treatments were well tolerated; headache and postural hypotension were the most common adverse events, while retrograde ejaculation occurred more frequently with Silodosin. Serious events such as palpitation and syncope were rare and manageable, with no significant differences in vital signs. Conclusion Silodosin (Silorap ® ) and Tamsulosin (Tamsolin ® ) are effective and well tolerated for medical expulsive therapy in distal ureteral stones. Silodosin achieved a higher stone expulsion rate, though time to expulsion was similar between groups. Trial registration ClinicalTrials.gov ID NCT05977647; Date of registration: 2023-08-04.
Authors
- Abdul Hafeez Qureshi (ORCID: https://orcid.org/0000-0002-9417-0128)
- Aziz Ur Rehman (ORCID: https://orcid.org/0000-0003-4665-781X)
- Hafiz Shahzad Ashraf
- Salman El Khalid (ORCID: https://orcid.org/0000-0002-8447-024X)
- Jahanzeb Kamal Khan (ORCID: https://orcid.org/0000-0001-6259-4332)
- Shahzad Anwar (ORCID: https://orcid.org/0000-0001-9873-726X)
- Irfan Nazir (ORCID: https://orcid.org/0000-0002-9321-9137)
- Javed Altaf
- Aziz Abdullah (ORCID: https://orcid.org/0009-0004-3201-8341)
- Shahbaz Hanif (ORCID: https://orcid.org/0009-0002-4553-4404)
- Muhammad Hammad Ali Mithani (ORCID: https://orcid.org/0000-0002-2166-7248)
- Muhammad Nasir Jamil (ORCID: https://orcid.org/0000-0002-4924-081X)
- Muhammad Nawaz
- Mahaveer Maheshwari
- Hayat Kakar (ORCID: https://orcid.org/0009-0003-6199-7836)
- Sayyed Ali Imran Zaidi (ORCID: https://orcid.org/0009-0008-8777-5322)
- Liaquat Ali (ORCID: https://orcid.org/0000-0003-3882-7487)
- Arshia Khan
- Asad Ullah Langove (ORCID: https://orcid.org/0009-0003-2129-4634)
- Ghulam Mahboob Subhani
Institutions
- Liaquat University of Medical & Health Sciences (PK)
- Ayub Medical College (PK)
- Allama Iqbal Medical College (PK)
- University of Balochistan (PK)
- Armed Forces Institute of Pathology (PK)
- Punjab Medical College (PK)
- Liaquat National Hospital (PK)
- Khyber Teaching Hospital (PK)
- Shalamar Hospital (PK)
- Government of Pakistan (PK)
- Indus Hospital (PK)
- Bolan University of Medical and Health Sciences (PK)
- College of Physicians and Surgeons Pakistan (PK)
- Shaheed Zulfiqar Ali Bhutto Institute of Science and Technology (PK)
- Dow University of Health Sciences (PK)
- Muhammad Nawaz Shareef University of Agriculture (PK)
- Northwest General Hospital and Research Center (PK)
- Khawaja Farid Social Security Hospital (PK)
- Kidney Centre (PK)
- Shaikh Zayed Postgraduate Medical Institute (PK)
Publication Details
- Journal
- BMC Urology
- Published
- 2026-08-20
- DOI
- https://doi.org/10.1186/s12894-026-02310-2
- Primary Topic
- Kidney Stones and Urolithiasis Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00